CN103189005A - Reduced extravasation of bone cement - Google Patents

Reduced extravasation of bone cement Download PDF

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Publication number
CN103189005A
CN103189005A CN2011800513971A CN201180051397A CN103189005A CN 103189005 A CN103189005 A CN 103189005A CN 2011800513971 A CN2011800513971 A CN 2011800513971A CN 201180051397 A CN201180051397 A CN 201180051397A CN 103189005 A CN103189005 A CN 103189005A
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China
Prior art keywords
bone
vertebral body
bone cement
sealant
cement
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CN2011800513971A
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Chinese (zh)
Inventor
B·E·斯蒂尔
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Medtronic PLC
Medtronic Spine LLC
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Kyphon Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3472—Trocars; Puncturing needles for bones, e.g. intraosseus injections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7097—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants
    • A61B17/7098—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants wherein the implant is permeable or has openings, e.g. fenestrated screw
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/885—Tools for expanding or compacting bones or discs or cavities therein
    • A61B17/8852—Tools for expanding or compacting bones or discs or cavities therein capable of being assembled or enlarged, or changing shape, inside the bone or disc
    • A61B17/8855—Tools for expanding or compacting bones or discs or cavities therein capable of being assembled or enlarged, or changing shape, inside the bone or disc inflatable, e.g. kyphoplasty balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/001—Use of materials characterised by their function or physical properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/08—Polysaccharides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/20—Polysaccharides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/06—Flowable or injectable implant compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

Abstract

The risk of bone cement extravasation can be reduced by delivering a calcium-dependent polymerizing sealant into a bone structure prior to delivery of bone cement into that structure. The polymerization of the sealant in response to the calcium within the bone structure can fill cracks and any other potential cement leakage paths, thereby minimizing the potential for subsequent extravasation. The benefits of the use of a calcium-dependent polymerizing sealant can be provided in any procedure involving the use of bone cement, such as spinal fixation, vertebroplasty, and kyphoplasty, among others.

Description

Reduce oozing out of bone cement
Background
The present invention generally relates to medical treatment device and program, and relates more specifically to medical treatment device and the program of oozing out at surgery intra-operative bone cement be used to preventing.
Bone cement is the term that is commonly used to refer to polymethyl methacrylate (PMMA), and it is commonly used to strengthen or strengthen bone structure.For example, bone screw usually is used for bone structure is stabilized in the health, for example during the spinal fracture prosthesis etc.This type of bone screw can be in conjunction with implanting (and therefore be sometimes referred to as pedicle screw) in pedicle of vertebral arch such as other structural elements of bar, bar and/or plate, in order to aim at and stablize impaired spinal column.
Regrettably, in implanting the host bone structure after, bone screw may be easy to become and " be extracted " from the host bone structure, becomes flexible in the host bone structure and/or unstability in the host bone structure.When in the soft (for example, spongy bone or sick bone) of the implanted bone structure of bone screw and/or bone screw when standing high load, bone screw for extract, liability loosening and/or unstability may be more serious.
Therefore, usually use bone cement to increase the pull-out strength of known bone screw.For example, developed the porose screw of a plurality of perforation that comprise center groove (sleeve pipe) and edge axle.So the bone cement that injects by the center groove can be distributed to skeleton on every side by perforation, makes more firm screw fixedly become possible enhancing structure thereby provide.
Yet, in such operation, use bone cement to bring extra risk, particularly from the bone environment, ooze out the risk that is associated with bone cement.The polyreaction of PMMA is to cause the exothermic reaction of flanking cell necrosis.In addition, when allowing its contact vascular or nerve, PMMA presents the toxicity that can cause pulmonary infarction or neurological handicap.This risk of oozing out exists in other operation such as vertebroplasty and kyphoplasty art of using bone cement.
Therefore, be desirable to provide a kind of be used to the system and method that oozes out risk during the surgical operation that minimizes the use that relates to bone cement.
General introduction
Be applied to the targeted bone structure by the polymeric encapsulant (for example sodium alginate) that before sending bone cement, will depend on calcium, can stop up the leakage passage of bone cement, thereby prevent that advantageously bone cement from oozing out.
In one embodiment, be used for to promote the Ca-dependent polymeric encapsulant can be delivered to bone structure before the sending of bone cement that screw is fixing.In certain embodiments, sending of sealant and/or bone cement can be carried out via the perforation in (a plurality of) bone screw.
In another embodiment, vertebroplasty may relate to sent the Ca-dependent polymeric encapsulant before bone cement is injected vertebral body.In various embodiments, the injection of sealant and bone cement can be undertaken by identical or different pin.
In another embodiment, the kyphoplasty art is delivered to the Ca-dependent polymeric encapsulant in this cavity before may relating in the preform cavity that bone cement is delivered in the vertebral body.In various embodiments, sealant and bone cement can be sent by identical or different delivery nozzles.
In various other embodiment, the surgery external member can comprise for carrying out operating system, a certain amount of Ca-dependent polymeric encapsulant and be used for the description of Ca-dependent polymeric encapsulant for system in skeleton.In various embodiments, this system can comprise bone screw, vertebroplasty pin or be used for the cavity formation device of kyphoplasty art, and the apparatus/hardware of other type.
As skilled in the art will recognize, the many different embodiment for the method and system of the leakage passage of sealing skeleton before sending at bone cement according to the present invention is possible.Set forth in the exemplary embodiment that other purposes, advantage and feature of the present invention discussed in the specific embodiment of this paper, and after reading following content, will become more obvious for those skilled in the art.
The accompanying drawing summary
Figure 1A-1D shows the exemplary pedicle screw implantation of the use that comprises the Ca-dependent polymeric encapsulant.
Fig. 2 A-2D shows the exemplary vertebroplasty of the use that comprises the Ca-dependent polymeric encapsulant.
Fig. 3 A-3G shows the exemplary kyphoplasty art of the use that comprises the Ca-dependent polymeric encapsulant.
Describe in detail
By before sending bone cement, Ca-dependent polymeric encapsulant (for example sodium alginate) being applied to the targeted bone structure, can stop up the leakage passage of bone cement, thereby prevent that advantageously bone cement from oozing out.
Figure 1A-1D shows the fixture of the use that relates to the bone cement that keeps for reinforcement to the exemplary insertion of skeleton.Figure 1A shows the cross section of vertebral body 100.Vertebral body 100 comprises the compact bone 100-W around spongy bone 100-C.Should be noted that, though property purpose and describe and described human vertebra presented for purpose of illustration herein, but in various other embodiment, skeleton, animal skeleton that vertebral body 100 also can replace to any other type are (for example, be used for veterinary's operation) or even corpse or artificial bone's (for example, being used for training or test procedure).
In Figure 1A, passage for example forms structure 110A and 110B(, guide wire, awl and/or osteotome) be used for penetrating the pedicle of vertebral arch 100-P of vertebral body 100, and provide to the path of spongy bone 100-C.Should be pointed out that in various embodiments passage forms structure 110A and 110B can be presented as a plurality of apparatuses (for example, guide wire was awl then before this).
Then, in Figure 1B, bone screw 120A and 120B are inserted in the vertebral body 100 via pedicle of vertebral arch 100-P.Bone screw 120A and 120B comprise perforation 121A and 121B respectively, and the delivery path of the material that provides via (groove) 122A of the sleeve pipe in bone screw 120A and the 120B and 122B is provided respectively for perforation 121A and 121B.
Then, in Fig. 1 C, Ca-dependent polymeric encapsulant 130 is incorporated in the vertebral body 100 via bone screw 120A and 120B.Sealant 130 can comprise in response to calcium and thickening and/or the material of any kind of hardening, and can be delivered in the crack and crack of bone structure.
For example, in one embodiment, sealant 130 can comprise sodium alginate, its in response to such as exist in the bone structure those calcium ion and polymerization.Alginate by the beta-D-mannuronic acid (mannuronate) of (1-4)-connect (M) and α-L-guluronic acid (guluronatic) two homopolymerization blocks (G) form-hardness of crosslinked/polymerization that the relative concentration of M:G can change Ca-dependent.
In certain embodiments, the M:G ratio can be based on the required character of resulting polymers and is selected.For example, high M:G ratio can cause in sealing more effective more resilient polymer in the irregular or big gap and opening, and that low M:G ratio can cause in sealing the sclere of porous more is more effective than hard polymer.Yet, should be pointed out that such selection depends on the circumstances to a great extent, and in many cases, low M:G ratio may be that the big opening of sealing is required, and high M:G ratio may be that the intensive path of sealing is required.
It should also be noted that in certain embodiments sealant 130 can be multi-component material, wherein each component is mixed before can be in being delivered to bone structure, perhaps can be delivered in the bone structure successively or simultaneously.For example, in one embodiment, sealant 130 can be included in sends the calcium injection that is delivered to before or after the alginate in the vertebral body 100, and wherein the calcium of Zhu Ruing helps the more abundant polymerization of alginate.
For sealant 130 is introduced vertebral body 100, delivery system 131A and 131B are connected to bone screw 120A and 120B respectively.Delivery system 131A and 131B can be used to any system of sending sealant 130, comprise syringe, high-pressure injection system (for example, hydraulic pump, compression system, mechanical linkage/screw rod system) and/or automatization's feed system etc.
Then order about from the sealant 130 of delivery system 131A and 131B respectively by sleeve pipe 122A and 122B, and leave perforation 121A respectively and 121B enters into vertebral body 100.Sealant 130 flows in the vertebral body 100, fills crack and crack in spongy bone 100-C and/or the compact bone 100-W.Particularly, the calcium in the vertebral body 100 causes sealant 130 polymerizations and thickens, thereby provides required gap to fill in vertebral body 100.
In case realize the required sealing of vertebral body 100, just bone cement 140 can be delivered in the vertebral body 100 to be provided for the firm engagement of bone screw 120A and 120B, shown in Fig. 1 D.Especially, delivery system 141A and 141B are connected to bone screw 120A and 120B respectively.In certain embodiments, delivery system 141A and 141B can be respectively identical with delivery system 131A and 131B (for example, identical but be connected to (a plurality of) high-pressure injection system of reservoir of (a plurality of) bone cement 140 or (a plurality of) two chamber syringes etc.).In various other embodiment, delivery system 141A and 141B can be independent (with different alternatively) delivery system (for example, are used for than the hand gun of low viscosity sealant 130 and be used for the high-pressure injection system of viscosity higher bone cement 140).
Under any circumstance, order about from the bone cement 140 of delivery system 141A and 141B respectively by sleeve pipe 122A and 122B, and leave perforation 121A respectively and 121B enters vertebral body 100.Because the crack in the vertebral body 100 and other potential external path are all filled for sealed dose 130, bone cement 140 major parts are retained in bone screw 120A and the 120B zone on every side, thereby minimize the risk that bone cement oozes out.
For ease of above-mentioned operation, in certain embodiments, can provide the bone screw external member, the directions for use that it comprises bone screw 120A and 120B, a certain amount of sealant 130 and is used for sealant 130 is used with bone screw 120A and 120B.In various other embodiment, external member can comprise other hardware/apparatus, for example guide wire, awl, driver, delivery system and/or bone cement.
The beneficial effect of above-mentioned bone seal operation can advantageously be applied to relate to any operation of the use of bone cement.For example, Fig. 2 A-2D shows exemplary vertebroplasty, and wherein bone cement is injected in the vertebra of fracture to stablize spinal column impaired or reduction.Fig. 2 A show have vertebral body 201,202 and 203 human spine's a part.Should be noted that, though vertebral body 201,202 and 203 is property purpose and described and be described as human spine's a part presented for purpose of illustration, but in various other embodiment, vertebral body 201,202 and 203 can be animal bone (for example, be used for veterinary's operation) or corpse/artificial bone's (for example, being used for training or test procedure).
Vertebral body 202 is owing to vertebral compression fracture (VCF) 202-F that may cause by osteoporosis, with the reduction of the skeleton of related to cancer and/or physical trauma caves in.VCF202-F forms the gryposis CK of spinal column, and this bending can cause the further fracture of serious pain and adjacent vertebral bodies.
In one embodiment, inject bone cement immediately instead of the vertebral body 202 of fracture, can inject Ca-dependent polymeric encapsulant 230(for vertebral body 202 and be similar to the described sealant 130 with reference to Figure 1A-1D, for example comprise the sealant of sodium alginate).Especially, pin 220(for example, straight, crooked, flexible and/or steerable pin) be positioned in the vertebral body 202 via direct insertion or in conjunction with additional apparatus (for example guide wire).In certain embodiments, sleeve pipe can be used to be provided to the admission passage of vertebral body 202.
Use the delivery system 235 that is connected to pin 220 that sealant 230 is delivered to vertebral body 202 then.Delivery system 235 can be used to any system of sending sealant 230, comprises syringe, high-pressure injection system (for example, hydraulic pump, compression system, mechanical linkage/screw rod system) and/or automatization's feed system etc.
Sealant 230 flows into vertebral body 202, fills the spongy bone 202-C of vertebral body 202 and/or crack and the crack in the compact bone.Particularly, the calcium in the vertebral body 202 causes sealant 230 polymerizations and thickens, thereby provides required gap to fill in vertebral body 202.
In case realized the required sealing of vertebral body 202, just bone cement 240 can be delivered in the vertebral body 202, shown in Fig. 2 C.Especially, delivery system 245 can be connected to pin 220 and enters in the vertebral body 202 by pin 220 to order about bone cement 240.
In certain embodiments, delivery system 245 can be 235 identical with delivery system (for example, identical but be connected to the high-pressure injection system of the reservoir of bone cement 240, or two chamber syringes etc.).In various other embodiment, delivery system 245 can be independent (with different alternatively) delivery system (for example, is used for than the syringe of low viscosity sealant 230 and be used for the high-pressure injection system of viscosity higher bone cement 240).
It should also be noted that in certain embodiments delivery system 235 all can be sent sealant 230 and bone cement 240 respectively by identical pin 220 with 245.In other embodiments, different pins 220 can be used for delivery system 235 and 245.
Under any circumstance, because the crack in the vertebral body 202 and other potential external path are all filled for sealed dose 230, bone cement 202 can be accommodated in the vertebral body 202, thereby minimizes the risk that bone cement oozes out.With regard to vertebroplasty, because the high cement delivery pressure and relative low viscous bone cement sending state used in operation, this may be particularly advantageous.In case the bone cement 240 of aequum is delivered in the vertebral body 202, i.e. removable pin 220, thus strengthen and stable vertebral body 202 by the bone cement 240 of sclerosis.
For ease of above-mentioned operation, in certain embodiments, can provide the vertebroplasty external member, the directions for use that it comprises pin 220, a certain amount of sealant 230 and is used for using sealant 230 and pin 220.In various other embodiment, external member can comprise other hardware/apparatus, for example guide wire, brill, driver, delivery system and/or bone cement.
The kyphoplasty art is another kind of VCF therapeutic scheme, and this scheme has solved the many problems that are associated with vertebroplasty.In the kyphoplasty art, the cavity that form to limit in the vertebral body of fracture is to admit and to hold the bone cement of sending subsequently.The cavity of kyphoplasty art forms operation also can recover some or all original height of vertebral body, thereby further strengthens the beneficial effect of operation.
Fig. 3 A-3G shows the use that comprises sealant with the exemplary kyphoplasty art of the risk that minimizes bone cement and ooze out.Fig. 3 A show have vertebral body 301,302 and 303 human spine's a part.Should be understood that, though vertebral body 301,302 and 303 is property purpose and described and be described as human spine's a part presented for purpose of illustration, but in various other embodiment, vertebral body 301,302 and 303 can be animal bone (for example, be used for veterinary's operation) or corpse/artificial bone's (for example, being used for training or test procedure).
Vertebral body 302 is owing to vertebral compression fracture (VCF) 302-F that may cause by osteoporosis, with the reduction of the skeleton of related to cancer and/or physical trauma caves in.VCF302-F forms the gryposis CK of spinal column, and this bending can cause the further fracture of serious pain and adjacent vertebral bodies.
Fig. 3 B shows the sleeve pipe 304 of next-door neighbour's targeted surgical site location, and this position is the spongy bone structure 302-C in the vertebra 302 of fracture in this case.Like this, provide the percutaneous path to vertebra 302 via the interior tube chamber 304-L of sleeve pipe 304.Usually, sleeve pipe 304 uses guide pin and/or dissector to be docked at the outer pars intramuralis (using the outer method of pedicle or pedicle of vertebral arch) of vertebral body, uses brill or other to enter the passage that instrument (scheming not shown) forms the spongy bone 302-C that further enters vertebra 302 then.Yet, also can use any other sleeve pipe method for posting to come locating sleeve 304.
In Fig. 3 C, cavity is formed device 350 insert in the sleeve pipe 304 then.Property purpose presented for purpose of illustration, cavity forms device 350 and is described and be described as expansible bone tamper, but in various other embodiment, cavity form device 350 can be can be in the spongy bone 302-C of vertebral body 302 interstitial any device, for example, mechanical cavity bodily form apparatus for converting (for example, support, rammer rod, agitator, osteotome or curette) or energy delivery system (for example, laser instrument, plasma or ultrasonic unit) etc.).
Cavity forms device 350 and comprises for example conduit of a 352(), at the expansible structure 351(of the far-end of axle 352 sacculus for example) and at the adapter 353(of the proximal end of axle 352 Luer lock accessory for example).Therefore expansible structure 351 can expand in spongy bone 302-C, shown in Fig. 3 D.This expansion can be by expansion fluid (for example, normal saline or contrast solution) for example being delivered to expansible structure 351(, syringe, pump or compression system etc.) any system (for clarity sake scheming not shown) carry out.
When expansible structure 351 was expanded with compress cancellous bony 302-C, its compact bone soleplate with vertebral body 302 was pushed open, and this may cause partially or completely highly recovering of vertebral body 302.In case expansible structure 351 has been expanded to volume required and/or has realized that in vertebra 302 desired height recovers, and just expansible structure 351 is shriveled and cavity is formed device 350 to remove from sleeve pipe 304.
The gained cavity 302-V that is formed in the spongy bone 302-C shown in Fig. 3 E provides the space that bone cement can be delivered to wherein.The spongy bone 302-C of compacting can form the obstacle to the hold bone cement, but may not can stop fully that all possible cement oozes out passage.
Therefore, delivery nozzles 320 can be positioned in the cavity 302-V via sleeve pipe 304, can use the delivery system 335 that is connected to delivery nozzles 320 that Ca-dependent polymeric encapsulant 330(is similar to respectively the sealant of describing with reference to Figure 1A-1D and Fig. 2 A-2D 130 and 230 then, for example comprise the sealant of sodium alginate) be delivered to vertebral body 302.
Sealant 330 flows into vertebral body 302, fills the spongy bone 302-C of vertebral body 302 and/or crack and the crack in the compact bone.Particularly, the calcium in the vertebral body 302 causes sealant 330 polymerizations and thickens, thereby provides required gap to fill in vertebral body 302.
Should be pointed out that delivery system 335 can be used to any system of sending sealant 330, comprise syringe, high-pressure injection system (for example, hydraulic pump, compression system, mechanical linkage/screw rod system) and/or automatization's feed system etc.
Should also be noted that delivery nozzles 320 can be for any structure that sealant 330 is transported to vertebral body 302.Though property purpose and delivery nozzles 320 is depicted as (for example provides the targeted delivery of sealant 330 in cavity 302-V presented for purpose of illustration, spraying), but in various other embodiment, what delivery nozzles 320 can provide any kind sends distribution (for example, omnidirectional, distribute or be used for any other delivery mechanism of high pressure or low pressure delivery based on the distribution on top, perforation).
In case realized the required sealing of vertebral body 302, just bone cement 302 can be delivered in the vertebral body 340, shown in Fig. 3 F.Especially, delivery nozzles 321 can be positioned in the cavity 302-V via sleeve pipe 304, and delivery system 345 can be connected to delivery nozzles 321 and enters among the cavity 302-V to order about bone cement 340.Delivery system 345 can be for any system that bone cement 340 is delivered to vertebral body 302 by delivery nozzles 321, for example, syringe, high-pressure injection system (for example, hydraulic pump, compression system, mechanical linkage/screw rod system) and/or automatization's feed system etc.
In certain embodiments, delivery system 345 can be 335 identical with delivery system (for example, identical but be connected to the high-pressure injection system of the reservoir of bone cement 340, or two chamber syringes etc.).In various other embodiment, delivery system 345 can be independent (with different alternatively) delivery system (for example, is used for than the syringe of low viscosity sealant 330 and be used for the high-pressure injection system of viscosity higher bone cement 340).
Should be pointed out that in certain embodiments delivery nozzles 320 can be identical apparatus with 321, make delivery system 335 respectively sealant 330 be sent by identical delivery nozzles with bone cement 340 with 345.In other embodiments, different delivery nozzles 320 and 321 can be used with delivery system 335 and 345 respectively.Should also be noted that in various other embodiment bone cement 340 can be sent (being biological preparation after the bone cement for example) in a plurality of parts of identical or different material.
Under any circumstance, because the crack in the vertebral body 302 and other potential external path are all filled for sealed dose 330, bone cement 340 can major part be accommodated in the cavity 302-V, thereby minimizes the risk that bone cement oozes out.In case the bone cement 340 of aequum is delivered in the vertebral body 302, just from vertebra 302(and patient's body) remove delivery nozzles 321 and sleeve pipe 304, shown in Fig. 3 G.
After sclerosis, bone cement 340 provides support structure for vertebra 302, thereby recovers the structural intergrity of skeleton and the correct muscle skeleton aligning of spinal column basically.Shown in Fig. 3 G, because the recovery of vertebra 302 height of fracture, the gryposis CK shown in Fig. 3 A corrects and is normal crooked CN.Like this, can solve the pain of vertebral compression fracture and the side effect of following by the kyphoplasty art of Wicresoft.
In order to be conducive to above-mentioned operation, in certain embodiments, kyphoplasty art external member can be provided, and it comprises the directions for use that sleeve pipe 304, cavity form device 350, delivery nozzles 320, a certain amount of sealant 330 and be used for using sealant 330 and delivery nozzles 320.In various other embodiment, external member can comprise other hardware/apparatus, for example guide wire, brill, driver, delivery system and/or bone cement.
Though various embodiment of the present invention has been described above, should be appreciated that they only with for example rather than ways to restrain provide.When the indication of said method and step with certain order some event takes place, benefit from those of ordinary skill in the art of the present disclosure and will recognize that the order of some step can be modified, and such modification is carried out according to modification of the present invention.In addition, some step can be carried out in parallel procedure when possibility simultaneously, and carries out successively as mentioned above.Therefore, range of the present invention and scope should not be subjected in above-described embodiment the restriction of any, and should only limit according to claims and their equivalent.Though illustrate and described the present invention especially with reference to its specific embodiment, should be appreciated that and to carry out various modifications in the form and details.

Claims (4)

1. external member comprises:
System, described system is for the treatment of bone structure;
The Ca-dependent polymeric encapsulant; And
Directions for use, described directions for use are used for described Ca-dependent polymeric encapsulant and use for the treatment of the described system of described bone structure.
2. external member as claimed in claim 1 is characterized in that, described system comprises at least one bone screw.
3. external member as claimed in claim 1 is characterized in that, described bone structure comprises vertebral body, and
Wherein, described system comprises for the pin that described Ca-dependent polymeric encapsulant is delivered to described vertebral body.
4. external member as claimed in claim 1 is characterized in that, described bone structure comprises vertebral body, and
Wherein, described system comprises:
Sleeve pipe, described sleeve pipe is used for being set up to the admission passage of described vertebral body;
Cavity forms device, and described cavity forms device and is used for forming cavity by described sleeve pipe in described vertebral body; And
Delivery nozzles, being dimensioned to by described sleeve pipe of described delivery nozzles mated, in order to described Ca-dependent polymeric encapsulant is delivered in the described cavity.
CN2011800513971A 2010-10-29 2011-10-26 Reduced extravasation of bone cement Pending CN103189005A (en)

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US20120109139A1 (en) 2012-05-03
EP2632354B1 (en) 2020-03-04
US11234748B2 (en) 2022-02-01
US9549760B2 (en) 2017-01-24
EP2632354A4 (en) 2015-04-22
AU2011319940A1 (en) 2013-05-30
US20180325571A1 (en) 2018-11-15
US10045805B2 (en) 2018-08-14
EP2632354A2 (en) 2013-09-04
US20170086898A1 (en) 2017-03-30
US20200305941A1 (en) 2020-10-01
WO2012058305A2 (en) 2012-05-03
US10695116B2 (en) 2020-06-30

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